Why choose Signature GYN for your Clinical Trial?
As the PI of our site, I work closely with my staff throughout all aspects of our trials including
- Trial selection
- Site qualification visits
- Prescreening of patients
- Development of source documents and site SOPs
- Site initiation visits
- I personally perform the needed assessments at each visit as well as meet with patients at other visits to monitor patient progress and assess AEs
- Monitor visits audits and close out visits
- Because of the size and structure of our site, decisions can be made quickly. There are no committees or boards that must give approval. Decisions and paperwork can be turned around in a few days, not weeks or months, so we can work efficiently with sponsors and be responsive to your needs.
Many of our study subjects are recruited from our current, diverse patient base. Our office is already convenient and accessible to them thus improving compliance, retention and follow up. And with a single provider, there is a greater consistency in evaluations and assessments. In summary, we are uniquely positioned to meet and exceed our recruitment goals producing quality data in a timely fashion.
John Whitfield, MD
Who is Signature GYN Services?
Signature GYN Services is research facility specializing in phase II-IV clinical trials in women’s healthcare. As part of a full-time gynecology practice in a large urban metroplex, we are accessible to a large population base. We treat a variety of gynecological problems including endometriosis, uterine fibroids, menopausal symptoms, STD testing, and provide contraceptive services on a daily basis.
As a full-service GYN office and research site, our facility includes:
- 3 exam rooms
- In-office sonography
- -20° degree freezer, locked drug storage, centrifuge
- EKG, venipuncture, Paps, endometrial biopsy
- Mammograms and DEXA on site
- Crash cart, AED
- Office is located on campus of full-service hospital and ER
- Patients have 24/7 access to physician
- Conference room with large screen monitor for presentations
- Study monitors given private area with internet access, photocopying and breakroom facilities
- Office conveniently located within 5 minutes of hotels and dozens of restaurants
- e-Source and e-Regulatory giving monitors remote access, thus allowing them to stay current with trial progress and reduce the amount of time required to be physically on-site